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KYSCO Industry News

From Gilead:  On 9/13/2021,  the NCCN updated Trodelvy’s recommendation within their 2021 Breast Cancer guidelines to a preferred regimen for mTNBC, also updating indication language to be consistent with Trodelvy’s indication as of April 2021. g (Version 8.2021). g For adult patients with metastatic TNBC who received at least two prior therapies, with at least one line for metastatic disease.  Link to URL of updated guideline: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf (Note requires NCCN account).

From G1 Therapeutics:  G1 Therapeutics, Inc. secures permanent J Code for COSELA™ (trilaciclib). The code, J1448, is effective on October 1, 2021. Visit COSELA.com for more information.

From Janssen: Janssen has announced the new Compass program that offers a single point of contact for patients, care partners, and professionals for navigation and support. More information here.

From Bristol Myers Squibb:  On August 20, 2021, the U.S. Food and Drug Administration approves Opdivo® (nivolumab) for the adjuvant treatment of patients with high-risk urothelial carcinoma. Read the full press release here.

From Janssen:  Janssen has announced that RYBREVANT™ (amivantamab-vmjw) is now included in the Janssen CarePath Savings Program. Eligible patients pay just $5 for each infusion and receive savings on their out-of-pocket medication costs, including deductible, co-pay, and co-insurance for their Janssen medication, up to a $26,000 maximum program benefit per calendar year. There is no income requirement. More information here.

From Janssen: FDA has approved RYBREVANT™ for the treatment of adult patients with metastatic NSCLC with EGFR exon 20 insertion mutations. This news is based on results from the Phase 1 CHRYSALIS study and follows the FDA’s decisions in March 2020 to grant Breakthrough Therapy Designation and in December 2020 to initiate Priority Review of the Biologics License Application. This approval makes RYBREVANT™ the first fully-human, bispecific antibody authorized for the treatment of patients with NSCLC that targets EGFR exon 20 insertion mutations, which are the third most prevalent activating EGFR mutation. See the Janssen news release here and view the announcement on Twitter here.

From Gilead: FDA grants accelerated approval to TRODELVY® for the treatment of metastatic urothelial cancer. Click here for more information.

From Gilead: FDA Approves TRODELVY®, the first treatment for metastatic triple-negative breast cancer shown to improve progression-free survival and overall survival. Click here for more information.

From Sanofi: Sanofi is pleased to announce that SARCLISA® (isatuximab-irfc) is now approved, in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. For more information, click here. Read the press release .

From G1 Therapeutics and Boehringer Ingelheim: G1 Therapeutics and Boehringer Ingelheim announce commercial availability of COSELATM (trilaciclib). For more information please see the press release here and visit www.COSELA.com.

From EMD Serono Inc.: EMD Serono, Inc. is pleased to announce that on February 3, 2021 the U.S. Food and Drug Administration (FDA) approved TEPMETKO® (tepotinib). Please see Full Prescribing Information for TEPMETKO (tepotinib) for more information.

From Daiichi Sankyo and AstraZeneca: Daiichi Sankyo and AstraZeneca are excited to announce that ENHERTU® (fam-trastuzumab deruxtecan-nxki) is now approved for a new indication. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate that was recently approved for use in adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. More information can be found here. Please be aware of the “Boxed Warnings” and other important safety information. For example, “ENHERTU has Boxed WARNINGS for Interstitial Lung Disease/Pneumonitis and Embryo-Fetal Toxicity. Please review full Prescribing Information for additional information.

From AstraZeneca: AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved TAGRISSO® (osimertinib) for adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Find out more.

From Gilead: Gilead has announced that CMS has issued a new J-Code for TRODELVY (sacituzumab govitecan-hziy) and published the payment limits and the NDC to HCPCs cross-walk file on their website. Effective for dates of service on or after January 1, 2021, the new HCPCS code for TRODELVY is J9317 and the billing increment is 2.5 mg. Find out more.

From Janssen Pharmaceutical Companies of Johnson & Johnson: On December 3, 2020, Janssen announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for amivantamab, an investigational, fully-human epidermal growth factor receptor (EGFR) and mesenchymal epithelial transition factor (MET) bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR and MET mutations and amplifications. Find out more.

From AstraZeneca: AstraZeneca announces important dosing information for unresectable Stage III non-small cell lung cancer (NSCLC) following chemoradiotherapy. Options are available for weight-based 2-week or fixed 4-week dosing with IMFINZI, allowing patients to receive IMFINZI at the frequency that best suits their schedules. Find out more.

From Immunomedics: Immunomedics announces a new C-Code (C-9066) for Trodelvy (sacituzumab govitecan-hziy), a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.The C-Code is effective October 1, 2020. Find out more.

From Lilly: As part of a national initiative to improve access to newly approved treatments, Lilly Oncology is offering a free thyroid testing program to help determine if patients have a genetic alteration that may inform therapeutic decisions. Please review the details outlined here and save this form to request a test for your patient as the need arises.

From Astellas and Seattle Genetics: Astellas and Seattle Genetics are pleased to announce the assignment of a product-specific, permanent J-code for PADCEV. The Centers for Medicare & Medicaid Services (CMS) released the July 2020 Quarterly Healthcare Common Procedural Coding System (HCPCS) File, which includes the designation of J9177 for PADCEV with the effective date of July 1, 2020. Find out more.

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